UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046324 |
|---|---|
| Receipt number | R000052862 |
| Scientific Title | Qol Pharmacy Clinical Study of usefulness of outpatient cancer patients PRO-CTCAE for continuous pharmacy management : multicenter joint research |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2023/06/09 16:40:24 |
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Basic information
Public title
Qol Pharmacy Clinical Study of usefulness of outpatient cancer patients PRO-CTCAE for continuous pharmacy management: multicenter joint research
Acronym
QOLMIND study
Scientific Title
Qol Pharmacy Clinical Study of usefulness of outpatient cancer patients PRO-CTCAE for continuous pharmacy management : multicenter joint research
Scientific Title:Acronym
QOLMIND study
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is continuous pharmaceutical by electronically collecting PRO-CTCAE or by conventional telephone follow-up for patients undergoing cancer drug therapy with oral anticancer drugs. It is to investigate the influence on the response contents of the pharmacy pharmacist when the management is enforced.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In the computerized PRO-CTCAE group and telephone follow-up group, the average value of the number of life guidance, medication guidance, information provided to medical institutions, and emergency information provided to medical institutions per subject was calculated. Estimate the 95% confidence interval.
Key secondary outcomes
1.Calculation of the average number of prescription changes, number of unscheduled consultations, treatment interruptions or hospitalizations per subject, and estimation of 95% confidence interval.
2.Descriptive statistical summary of information obtained from after-sales follow-up.
3.Calculation of average medication instruction time at the second visit and estimation of 95% confidence interval.
4.Calculation of average value of pharmacist reliability pre- and post-difference per subject and estimation of 95% confidence interval.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Currently receiving cancer therapy.
2.ECOG PS 0 to 2.
3.Sufficient language ability to understand and complete the questionnaire without assistance.
4.Provision of written informed consent.
Key exclusion criteria
1.Those who have difficulty in evaluating their own symptoms.
2.Those who have cognitive problems that make it difficult to evaluate their symptoms on their own.
3.Those who have mental problems that make it difficult to evaluate their symptoms on their own.
4.Those who are judged by the pharmacy pharmacist to be difficult to implement continuous pharmacy management guidance.
5.Those whose native language is not Japanese.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Naganuma |
Organization
Qol Co., Ltd.
Division name
Qol Academy, Education and Training Headquarters
Zip code
105-8452
Address
4-3-1 Toranomon, Minato-ku, Tokyo Shiroyama Trust Tower 37th floor
TEL
03-6430-9058
m-naganuma@qol-net.co.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Shimanuki |
Organization
Qol Co., Ltd.
Division name
Qol Academy, Education and Training Headquarters
Zip code
Qol Academy, Education and Training Headquarters
Address
4-3-1 Toranomon, Minato-ku, Tokyo Shiroyama Trust Tower 37th floor
TEL
03-6430-9058
Homepage URL
e-shimanuki@qol-net.co.jp
Sponsor or person
Institute
Qol Co., Ltd.
Qol Academy, Education and Training Headquarters
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare Scientific Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tohoku University School of Medicine.
Graduate School of Medicine, The University of Tokyo.
Tokyo University of Pharmacy and Life Sciences.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Qol Ethical Review Board
Address
4-3-1 Toranomon, Minato-ku, Tokyo Shiroyama Trust Tower 37th floor
Tel
03-6430-9058
qol-academy@qol-net.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
In this study, the patient after-sales follow-up method by the pharmacy pharmacist is performed by ePRO or telephone according to the patient's wishes. Patient-selected method (ePRO, telephone), pharmacy pharmacist response (life guidance, medication guidance, information provision to medical institutions, emergency contact to medical institutions), response results (prescription change, unreserved consultation, treatment interruption or hospitalization) , Patient background (age, gender, cancer type), pharmacy pharmacist reliability, medication guidance time at the time of prescription dispensing.
Management information
Registered date
| 2021 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052862
